NCT06205329已完成1 期
Phase I Study on the Safety, Tolerability, Pharmacokinetics, and Food Effect Evaluation of WPV01 and WPV01 Co-administrated Ritonavir in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- To evaluate the safety and tolerability of single and multiple oral doses of WPV01 and WPV01 in combination with ritonavir in healthy subjects.
研究概览
简要总结
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WPV01 and WPV01 Co-administrated With Ritonavir in Healthy Adult Subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects signed an informed consent form with full understanding of the test content, procedure and possible adverse effects
- •Chinese healthy male or female subjects between aged from 18 to 45 years
- •Subjects must agree to comply with the contraceptive requirements during the trial and for 3 months after the last dose
- •Body weight ≥ 50 kg for men and ≥ 45 kg for women and body mass index in the range of 18.0 ~ 28.0 kg/m2 (including 18.0 and 28.0)
- •Subjects must be willing to understand and comply with study procedures and limitations, have the ability to complete the trial as planned, and be able to communicate effectively with the investigator
排除标准
- •Participants who have special dietary requirements and cannot abide by the provided food
- •Pregnant or lactating women; Women who have pregnancy plan 1 month before trail, during trail or within 3 months after last dose; Women with positive serum pregnancy tests at screening or baseline
- •Participants who have evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic disease
- •Participants who have history of any other acute or chronic illness
- •Participants who have known allergy to any ingredient in the study treatment drug
- •Participants who are judged by the investigator to be unsuitable to participate in this study
研究组 & 干预措施
WPV01 Dose 1-4
Experimental
WPV01 Dose 1-4 or Placebo
干预措施: WPV01 Dose 1-4 (Drug)
WPV01 Dose 5-8
Experimental
WPV01 Dose 5-8 co-administrated with ritonavir or Placebo
干预措施: WPV01 Dose 5-8 and Ritonavir (Drug)
WPV01 Dose 9-12
Experimental
WPV01 Dose 9-12 or Placebo
干预措施: WPV01 Dose 9-12 (Drug)
WPV01 Dose 13-15
Experimental
WPV01 Dose 13-15 or Placebo
干预措施: WPV01 Dose 13-15 and Ritonavir (Drug)
WPV01 Dose 16
Experimental
WPV01 Dose 16(with high fat meal) or WPV01 Dose 16 (fed)
干预措施: WPV01 Dose 16 (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of single and multiple oral doses of WPV01 and WPV01 in combination with ritonavir in healthy subjects.
时间窗: Day 1 to Day 18
Adverse events, including type, incidence, grade (determined with reference to NCI-CTCAE V5.0)
次要结局
- Apparent Clearance (CL/F) in SAD(SAD part: Day 1 to Day 18)
- Maximum Plasma Concentration (Cmax) in Single Ascending Dose (SAD)(SAD part: Day 1 to Day 18)
- Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) in SAD(SAD part: Day 1 to Day 18)
- Time for Cmax (Tmax) in SAD(SAD part: Day 1 to Day 18)
- Apparent Volume of Distribution (Vz/F) in SAD(SAD part: Day 1 to Day 18)
- Cmax in Multiple Ascending Dose (MAD)(MAD part: Day 1 to Day 22)
- Time for Cmax (Tmax) in MAD(MAD part: Day 1 to Day 22)
- Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) in SAD(SAD part: Day 1 to Day 18)
- Terminal Elimination Half-Life (t½) in SAD(SAD part: Day 1 to Day 18)
- Area Under the Plasma Concentration-Time Profile From Time Zero To End of Dosing Interval (AUCtau) in MAD(MAD part: Day 1 to Day 22)
- To evaluate the metabolites of single oral doses of WPV01 and WPV01 in combination with ritonavir in healthy subjects(MAD part: Day 1 to Day 22)
- Cmax in Food Effect (FE)(Day 1 to Day 22)
- Tmax in FE(Day 1 to Day 22)
- Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) in FE(Day 1to Day 22)
研究者
研究点 (1)
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